Quality Assurance Manager

We are seeking a highly skilled and experienced Quality Manager to join our team. As a Quality Manager, you will be responsible for ensuring that our products meet the highest standards of quality and compliance with regulations. You will oversee all aspects of quality management, including analyzing data, implementing quality systems, conducting quality inspections, and performing quality control activities.

Duties:

- Develop and implement quality management systems and processes to ensure compliance with CGMP and FDA regulations

- Analyze data and trends to identify areas for improvement in product quality

- Conduct regular quality inspections to ensure adherence to specifications and standards

- Collaborate with cross-functional teams to resolve quality issues and implement corrective actions

- Perform internal audits and lead external audits to assess compliance with quality standards

- Develop and maintain documentation related to quality control procedures, including standard operating procedures (SOPs) and work instructions

- Conducts quality investigations /deviations and reviews corrective action plans for adequacy and compliance. This includes root cause analysis and product impact assessments for investigations resulting from deviations and OOS.

- Ensures appropriate CAPA actions are identified and addressed.

- Approves investigations/CAPAs.

- Train employees on quality control processes and procedures

- Monitor supplier performance and conduct supplier audits as necessary

- Stay up-to-date with industry trends and changes in regulations related to product quality

Requirements:

- Bachelor's degree in a relevant field, chemistry background

- Proven experience in quality management, preferably in a manufacturing or pharmaceutical environment

- Strong knowledge of CGMP regulations and FDA regulatory requirements

- Experience with quality inspection techniques and tools

- Excellent analytical skills with the ability to analyze data and identify trends

- Strong attention to detail and accuracy

- Effective communication skills, both written and verbal

- Ability to work collaboratively in a cross-functional team environment

- Strong problem-solving skills and the ability to implement effective corrective actions

- 3 plus years' experience in a similar position

- Ability to operate under deadlines while still meeting standards

- Ability to effectively lead, train, supervise, and motivate others to successful completion of goals

- Excellent organizational and time-management skills

- Clear and accurate data entry and documentation skills; strong follow-through and perseverance to handle multiple tasks simultaneously

- Strong competency working with integrated data systems, Microsoft Office Suite, including Outlook and intermediate to advanced Word and Excel (i.e., spreadsheets, formulas, importing and exporting of files, as applicable) as required

- Bilingual preferred

Job Type: Full-time, Monday through Friday, day shift

Pay: According to experience

Benefits:

• Health Insurance
• Dental Insurance
• Vision insurance
• Life insurance
• Paid Time Off

If you are a dedicated professional passionate about ensuring product quality, we invite you to apply for the position of Quality Manager. Join our team and contribute to our commitment to delivering high-quality products that meet customer expectations.